OMT to Improve Feeding After Hypothermia



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:12/22/2017
Start Date:October 24, 2017
End Date:April 2018
Contact:Alexa K Craig, MD
Email:craiga@mmc.org
Phone:207-396-7337

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Pilot Study Assessing the Effect of Osteopathic Manipulative Treatment (OMT) on Length of Stay in Infants With Neonatal Encephalopathy After Therapeutic Hypothermia

The goal of this study is to determine if infants with neonatal encephalopathy will achieve
full oral feeds faster after therapeutic hypothermia has completed if they are treated with
osteopathic manipulative treatment. The treated infants will be compared to matched
historical controls.

Infants affected by neonatal encephalopathy (NE) have been shown to have better survival
rates and improved long term neurodevelopment following treatment with therapeutic
hypothermia. However, a barrier to hospital discharge for these infants is a successful
transition from gavage to either breast or bottle feeding.

Often, the factor delaying hospital discharge is slow transition to full oral feeds.
Osteopathic manipulative treatment (OMT) helps to effectively stabilize and regulate the
autonomic nervous system as well as the cranial nerves important in the sucking and latching
reflexes, which may in turn help to ease the transition to full oral feeding. We hypothesize
that infants who receive OMT will accelerate the transition to full oral feeds, thus
decreasing their overall length of hospitalization compared to historical matched controls.

Inclusion Criteria:

- Neonate > 37 weeks gestational age at birth

- Neonate been diagnosed with neonatal encephalopathy or hypoxic ischemic encephalopathy
and treated with therapeutic hypothermia

- Neonate with mild to moderate encephalopathy

- EEG without seizure activity

- Brain MRI without basal ganglia injury

Exclusion Criteria:

- Neonate < 37 weeks gestational age at birth

- Neonate with severe encephalopathy (as defined by Sarnat)

- EEG demonstrated seizure activity or evidence of status epilepticus during therapeutic
hypothermia treatment

- Brain MRI demonstrating moderate or severe basal ganglia injury

- Neonate affected by neonatal abstinence syndrome (NAS)

- Neonate affected by intrauterine growth restriction (IUGR)

- Neonate born with major congenital anomalies (i.e., cleft palate)

- Prenatal history of maternal insulin dependent gestational or type 1 diabetes

- Moribund status (i.e., infants unlikely to benefit from or are not responsive to
aggressive life support)
We found this trial at
1
site
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Alexa K Craig, MD
Phone: 207-396-7337
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